RecruitingNCT06958107

LCI-SAR-BSTS-CTDNA-001: Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients

Prospective Clinical Evaluation of Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients

Sponsor

Wake Forest University Health Sciences

Enrollment

300 participants

Start Date

Aug 21, 2025

Study Type

OBSERVATIONAL

Conditions

Sarcoma

Summary

The purpose of this research study is to see how well Low Pass Whole Genome Sequencing (LP-WGS) can detect circulating tumor deoxyribonucleic acid (ctDNA) in the blood of participants who have bone or soft tissue sarcoma (type of cancer).

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is collecting blood samples from patients with sarcoma (a type of cancer that starts in bones or soft tissues) to detect and track cancer DNA circulating in the bloodstream. This "liquid biopsy" approach could allow doctors to monitor the cancer and its response to treatment without invasive tissue biopsies. **You may be eligible if...** - You are any age (including children, with appropriate consent) - You have a suspected or confirmed diagnosis of sarcoma, or you are a healthy volunteer - You are willing to provide blood samples at study-specified time points - A parent, legal guardian, or the participant themselves can provide informed consent **You may NOT be eligible if...** - You are unwilling or unable to provide informed consent or assent - You cannot provide blood samples as required by the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNon-Metastatic and Resectable

Blood Draw Timepoints: * Before any treatment begins * After Neo-adjuvant therapy (only if you receive this type of therapy) * After local surgery * After Adjuvant therapy (only if you receive this type of therapy) * Follow up after adjuvant therapy: at Months 3, 6, 9, 12, 15, 18, and 24 * After evidence of recurrence or worsening of disease, and then collected at standard of care disease evaluation visits up until 24 months from the last treatment for the initial diagnosis

OTHERMetastatic and Un-resectable

Blood Draw Timepoints: * Before any treatment begins * During standard of care disease evaluation visits for up to 24 months

OTHERNo evidence of disease, under surveillance

Blood Draw Timepoints: * From completion of treatment- at Months 3, 6, 9, 12, 15, 18, and 24; depending on when you enroll into the study you will start at the next timepoint in this schedule * After evidence of recurrence or worsening of disease, and then collected at standard of care disease evaluation visits up until 24 months from the last treatment for the initial diagnosis

OTHERALT or WDLS

Blood Draw Timepoints: • Collect once after surgery (up to six weeks after surgery)

Locations(2)

Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

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NCT06958107

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